Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

U

University of Barcelona

Status

Completed

Conditions

Type 2 Diabetes Mellitus
Chronic Periodontitis

Treatments

Procedure: Nonsurgical periodontal treatment
Procedure: Dental Prophylaxis

Study type

Interventional

Funder types

Other

Identifiers

NCT02652026
UBarcelona

Details and patient eligibility

About

The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.

Full description

Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years. Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria were:

  • Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
  • Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).

Exclusion criteria included:

  • Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
  • Having received non-surgical periodontal treatment within the past 6 months.
  • Pregnancy
  • Significant change of medication for diabetes during the course of the study
  • Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Treatment Group
Experimental group
Description:
The Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions
Treatment:
Procedure: Dental Prophylaxis
Procedure: Nonsurgical periodontal treatment
Control Group
Active Comparator group
Description:
The Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions
Treatment:
Procedure: Dental Prophylaxis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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